e-ULTIMASTER
Research type
Research Study
Full title
Prospective,single-arm, multi-centre, observational registry to further validate safety and efficacy of the ultimaster DES in real-world patients.
IRAS ID
155743
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Terumo Europe N.V.
Clinicaltrials.gov Identifier
Research summary
The e-ultimaster registry is an observational study that will collect clinical data on patients with coronary heart disease requiring treatment with the ultimaster coronary stent.
The purpose of the registry is to further determine the safety and effectiveness of the CE marked ultimaster drug eluting stent. To describe the procedure and patient outcome of patients worldwide. To identify rare events and look for predictors of adverse events.
The registry is inviting patients from centres across the world to participate. No additional tests or procedures are required, all treatment will be according to hospital routine practice. Data will be collected and analysed up to one year following the ultimaster procedure.
The purpose of the registry is to further determine the safety and effectiveness of the CE marked ultimaster drug eluting stent. To describe the procedure and patient outcome of patients worldwide. To identify rare events and look for predictors of adverse events.
The registry is inviting patients from centres across the world to participate. No additional tests or procedures are required, all treatment will be according to hospital routine practice. Data will be collected and analysed up to one year following the ultimaster procedure.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/1161
Date of REC Opinion
22 Jul 2014
REC opinion
Favourable Opinion